The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.

A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion

The results of an overall assessment of treatment by the subjects at 120 minutes post dose [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]

Total amount of drug intake [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Active Comparator: Arm 2

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Active Comparator: Arm 3

Drug: Pseudoephedrine

Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Placebo Comparator: Arm 4

Drug: Placebo

Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms associated with URTI during the last 4 days before study participation.- Other findings of URTI, confirmed on the physical examination.- Agreement to comply with the study requirements.- Written informed consent prior to enrollment in the study Exclusion Criteria:- Pregnant or lactating females.- Uncontrolled chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.- History of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing tissues within 2 hours before first intake of study drug.- Intake of any menthol containing product within 4 hours before first intake of study drug.- Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.- Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.- Intake of any analgesic within 12 hours before first intake of study drug.- Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.- Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial within the last 30 days.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01062360